420 Magazine Background

Another medical use for marijuana. . .

Thread starter #1


Synthetic Marijuana Reduces Agitation In Patients With Alzheimer's
San Antonio, Texas and Long Branch, N.J. (November 14, 2003) - Results from
a Phase II, multi-center study found dronabinol, a synthetic version of the
active ingredient in marijuana, reduces agitation in patients with
Alzheimer's disease. In addition, the research concluded that reduced
agitation may contribute to the relief of caregiver burden associated with
the condition. The findings were presented at the American Society of
Consultant Pharmacists' 34th annual meeting.
"Our results show dronabinol is an effective treatment for behavioral
agitation in patients with Alzheimer's and may ultimately help reduce the
stress often experienced by caregivers," said geriatrician Joel S. Ross,
M.D. a member of the teaching faculty at Monmouth Medical Center and the
lead investigator in the study. "While difficult for the patient, the
effects of agitation can greatly impact the emotional and physical health of
family members and caregivers. By reducing patients' agitation, caregivers
are able to focus more time and energy on their patients' overall
Dronabinol, marketed as Marinol, is synthetic delta-9-tetrahydrocannabinol
(delta-9-THC). Delta-9-THC also is a naturally occurring component of
Cannabis sativa L (marijuana). Dronabinol has been approved by the U.S. Food
and Drug Administration (FDA) for the treatment of anorexia in patients with
HIV/AIDS and for the treatment of nausea and vomiting associated with cancer
chemotherapy. Recent clinical tests also have examined dronabinol's
potential to relieve symptoms of multiple sclerosis.1
Agitation is the most common behavioral management problem in patients with
Alzheimer's and affects an estimated 75 percent of people with the disease.
It may lead to a variety of symptoms ranging from physical and/or verbal
abusive postures, physically non-aggressive conduct including pacing and
restlessness, as well as verbally disturbed behaviors such as screaming and
repetitive requests for attention.
More than 80 percent of caregivers report they frequently experience high
levels of stress, and nearly half say they suffer from depression, according
to the Alzheimer's Association.
The Phase II, open label, randomized, parallel-group study involved 54
community-dwelling patients at two sites, all who demonstrated behavioral
agitation (mean age = 81). All patients were over the age of 50 years and
met DSM-IV criteria for dementia related to Alzheimer's. The Mini-Mental
State Exam (MMSE) and the Cohen-Mansfield Agitation Inventory (CMAI) were
used to measure severity of Alzheimer's disease and agitation level,
respectively. Following a one-week qualifying period to evaluate the degree
of agitation, patients were screened on Day 0, evenly randomized to one of
two treatment groups (dronabinol 2.5 mg bid or dronabinol 5 mg bid) on Day
7, and returned for clinic visits on Day 21, Day 35 and Day 63. The primary
efficacy measurement was the CMAI, a 38-item rating scale that evaluates the
prevalence of pathological and disruptive behaviors. The secondary efficacy
measurements were the Caregiver's Burden Inventory (CBI), CGI Severity of
Alzheimer's disease (CGI-S AD), Instrumental Activities of Daily Living
Scale (IADL) and MMSE. Evaluation at nine weeks found significant reductions
of CMAI scores in both groups. There also was a trend toward a decrease in
CBI scores and increase in IADL scores in both groups, without a statistical
difference between the two doses. The 5 mg bid group experienced a trend
toward a decrease in CGI-S AD scores.
Doses could be adjusted during the study, allowing for a patient to receive
both doses of the medication and be included in both groups at the time of
evaluation for efficacy and adverse events. Adverse events experienced by
more the five percent of patients involved in the study included abnormal
gait, accidental injury, agitation, anxiety, asthenia, dizziness,
somnolence, spontaneous bone fracture and vomiting. Two deaths occurred in
the patient population, but investigators determined both were unrelated to
the medication.
Monmouth Medical Center, an affiliate of the Saint Barnabas Health Care
System, is a 527-bed community teaching hospital located in Long Branch, NJ.
For two decades, Monmouth Medical Center's geriatric program has been a
recognized leader in the development of unique health care services for
seniors. In 1982, a multidisciplinary geriatric team was established in
response to the growing needs of older adults. Today, the Greenwall
Geriatric Program at Monmouth coordinates health and social services for the
elderly and their families in a community-teaching-hospital environment.

This story has been adapted from a news release issued by Monmouth Medical

Nicholas V. Cozzi, Ph.D.
Department of Pharmacology & Toxicology
Brody School of Medicine
East Carolina University
Greenville, NC 27834

Source: Monmouth Medical Center
Date: 2003-11-18